FDA.reportPublic FDA data

MAUDE MDR 5945386

MDR report key
5945386
Report number
3005706359-2016-00001
Event key
0
Event type
3
Date of event
2016-05-23
Date received
2016-09-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS MIKKI DAVIS
Address
1665 LAKES PARKWAY SUITE 102 LAURENCEVILLE GA 30043 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IRRISEPTWOUND CLEANSERIRRIMAX CORPORATIONFQH403IRRISEPT-4035P014R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-1301. R

Event Narratives#

N

Patient 1

THIS REPORT WAS NOT FILED WITHIN THIRTY (30) DAYS OF BECOMING AWARE OF INFORMATION INCLUDED HEREIN DUE TO DELAYS IN THE EMDR REGISTRATION PROCESS. THIS REPORT WAS SUBMITTED AS SOON AS EMDR REGISTRATION WAS COMPLETE.

D

Patient 1

SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 5 AND WAS DIAGNOSED WITH A HEMATOMA. IT WAS REPORTED THAT KEFLEX WAS USED TO TREAT THE HEMATOMA. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT ALSO HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-00002).

N

Patient 1

IRRIMAX IS SUBMITTING THIS FOLLOW-UP REPORT IN ACCORDANCE WITH 21 CFR ? 803. THIS REPORT IS BASED ON INFORMATION PROVIDED TO IRRIMAX, WHICH IRRIMAX HAS NOT BEEN ABLE TO CONFIRM PRIOR TO THE DATE THIS FOLLOW-UP REPORT WAS SUBMITTED AND WILL NOT BE ABLE TO CONFIRM WITHOUT FURTHER ASSISTANCE FROM REPORTING PHYSICIAN.

D

Patient 1

SURGEON REPORTED THAT IT WAS THE USE OF IRRISEPT DURING A PRIMARY TOTAL KNEE REPLACEMENT THAT MAY HAVE CAUSED KNEE PAIN AND WOUND DAMAGE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM POSTOPERATIVE DAY 5 AND WAS DIAGNOSED WITH A HEMATOMA. IT WAS REPORTED THAT KEFLEX WAS USED TO TREAT THE HEMATOMA. ACCORDING TO INFORMATION PROVIDED TO IRRIMAX, SURGEON REPORTING THIS EVENT ALSO HAD ANOTHER PATIENT WITH KNEE PAIN AND WOUND DAMAGE WHO HAD UNDERGONE A PRIMARY TOTAL KNEE REPLACEMENT VISIT THE EMERGENCY ROOM ON THE SAME DAY AS THIS PATIENT (MFR REPORT# 3005706359-2016-0002). IN ADDITION, ON MAY 20, 2016, THE HOSPITAL WHERE THE EVENT REPORTEDLY OCCURRED WAS INSPECTED BY THE JOINT COMMISSION, WHICH, AS A RESULT OF THE INSPECTION, TEMPORARILY DENIED FULL ACCREDITATION AFTER THE HOSPITAL FAILED TO MEET MULTIPLE STANDARDS, INCLUDING THE FOLLOWING - "[T]HE HOSPITAL HAS AN INFECTION PREVENTION AND CONTROL PLAN" AND "[T]HE HOSPITAL REDUCES THE RISK OF INFECTIONS ASSOCIATED WITH MEDICAL EQUIPMENT, DEVICES AND SUPPLIES."